pravastatin sodium

Generic: pravastatin sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 80 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 84386-034
Product ID 84386-034_c21d4797-d252-4073-891f-330484c5f643
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077793
Listing Expiration 2026-12-31
Marketing Start 2025-02-27

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84386034
Hyphenated Format 84386-034

Supplemental Identifiers

RxCUI
904481
UPC
0384386034904
UNII
3M8608UQ61

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pravastatin sodium (source: ndc)
Generic Name pravastatin sodium (source: ndc)
Application Number ANDA077793 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (84386-034-90)
  • 1000 TABLET in 1 BOTTLE (84386-034-99)
source: ndc

Packages (2)

84386-034-90 90 TABLET in 1 BOTTLE (84386-034-90) 84386-034-99 1000 TABLET in 1 BOTTLE (84386-034-99)

Ingredients (1)

pravastatin sodium (80 mg/1)

Linked Drug Pages (1)

Pravastatin sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c21d4797-d252-4073-891f-330484c5f643", "openfda": {"upc": ["0384386034904"], "unii": ["3M8608UQ61"], "rxcui": ["904481"], "spl_set_id": ["c21d4797-d252-4073-891f-330484c5f643"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (84386-034-90)", "package_ndc": "84386-034-90", "marketing_start_date": "20250227"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (84386-034-99)", "package_ndc": "84386-034-99", "marketing_start_date": "20250227"}], "brand_name": "Pravastatin sodium", "product_id": "84386-034_c21d4797-d252-4073-891f-330484c5f643", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "84386-034", "generic_name": "Pravastatin sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pravastatin sodium", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "ANDA077793", "marketing_category": "ANDA", "marketing_start_date": "20250227", "listing_expiration_date": "20261231"}